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New hope for hemophilia a: phase 3 trial launches for Next-Gen bleed prevention

NCT ID NCT07416604

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study compares a new drug, NXT007, to an existing one (emicizumab) for preventing bleeding episodes in people aged 12 and older with hemophilia A. Participants may have severe, moderate, or mild disease, with or without factor VIII inhibitors. The goal is to see if NXT007 is more effective at reducing bleeds and improving quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of severe (FVIII:C \<1 International Unit per decilitre \[IU/dL\]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A with or without inhibitors against FVIII * Diagnosis of mild (FVIII:C between \>5 IU/dL and \<40 IU/dL) congenital hemophilia A with chronic FVIII inhibitors, defined as documented FVIII inhibitor ( ≥0.6 BU/mL or ≥1.0 BU/mL only for laboratories with a historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) and chronic reduction of endogenous baseline FVIII:C to \<5 IU/dL for ≥12 months * Documented historical FVIII inhibitor assay results within the 12 months prior to enrollment * Documentation of the details of prophylactic and episodic FVIII treatment, bypassing agent (BPA) treatment, emicizumab prophylaxis treatment, and the number and type of bleeding episodes for at least the last 6 months prior to screening * For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with either emicizumab or NXT007, according to assigned randomization Exclusion Criteria: * Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for antiretroviral therapy to treat HIV * Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario * Planned surgery (excluding minor procedures, such as non-molar tooth extraction or incision and drainage) during the study * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing) * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence or clinical history of prior myocardial infarction

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites in 19 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP - Hôpital Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, Val-de-Marne, 94270, France

  • Arbesu Hematologia

    RECRUITING

    Godoy Cruz, Mendoza Province, M5504FKD, Argentina

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • CHU de Lille - Institut Cœur Poumon

    RECRUITING

    Lille, 59037, France

  • Center for Inherited Blood Disorders

    RECRUITING

    Orange, California, 92868, United States

  • Chengdu Women's and Children's Central Hospital

    RECRUITING

    Chengdu, Sichuan, 610073, China

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    RECRUITING

    Debrecen, Pest County, 4032, Hungary

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Lombardy, 20122, Italy

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, 371-8511, Japan

  • Haemophilia Comprehensive Care Centre

    RECRUITING

    Parktown, Gauteng, 2193, South Africa

  • Hospices Civils de Lyon

    RECRUITING

    Bron, 69500, France

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

    RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital Regional Universitario de Malaga ? Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario La Paz - PPDS

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    RECRUITING

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • Innovative Hematology, Inc.

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    SUSPENDED

    Tianjin, Tianjin Municipality, 301617, China

  • Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli

    RECRUITING

    Rosario, Santa Fe Province, S2000CFK, Argentina

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, 41944, South Korea

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aiti, 466-8560, Japan

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Nara Medical University Hospital

    RECRUITING

    Kashihara-shi, Nara, 634-8522, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Ogikubo Hospital

    RECRUITING

    Suginami-Ku, Tokyo, 167-0035, Japan

  • Rigshospitalet

    RECRUITING

    København Ø, Capital, 2100, Denmark

  • St Joseph's Children's Hospital of Tampa

    RECRUITING

    Tampa, Florida, 33607-6307, United States

  • The Chaim Sheba Medical Center - PPDS

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • The Royal London Hospital

    RECRUITING

    London, Middlesex, E1 1FR, United Kingdom

  • UZ Leuven

    RECRUITING

    Leuven, Antwerp, 3000, Belgium

  • Universitair Medisch Centrum Utrecht Cancer Center - PPDS

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University Of Iowa Hospitals And Clinics

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • University of Colorado Hemophilia and Thrombosis Center

    RECRUITING

    Aurora, Colorado, 80045-7202, United States

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Washington Center for Bleeding Disorders

    RECRUITING

    Seattle, Washington, 98101-3932, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.